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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV SPHN/UNIT CAT CERTAS PLUS W/ SG

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INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV SPHN/UNIT CAT CERTAS PLUS W/ SG Back to Search Results
Catalog Number 828806
Device Problem Complete Blockage (1094)
Patient Problem Failure of Implant (1924)
Event Date 03/26/2021
Event Type  Injury  
Manufacturer Narrative
An investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
A physician reported an occluded shunt valve. A certas plus in-line valve was implanted in a patient via a ventricular peritoneal shunt secondary to a subarachnoid hemorrhage on an unknown date with an initial setting of 1. On an unknown date, the ventricles expanded and did not change when the pressure was changed. After pumping the shunt valve, the flow of cerebrospinal fluid could be confirmed temporarily, but it was immediately occluded. After confirming that the cerebrospinal fluid was not flowing, the patient was taken to the operating room on (b)(6) 2021 for a shunt valve revision. The patient recovered.
 
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Brand NameCERTAS INLIN VLV SPHN/UNIT CAT
Type of DeviceCERTAS PLUS W/ SG
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
rue girardet 29
le locle
SZ
Manufacturer (Section G)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
ch-2400
le locle
SZ
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key11699351
MDR Text Key247044215
Report Number3013886523-2021-00175
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K143111
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number828806
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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